The purpose of this article is to introduce the importance of creating and implementing a quality plan intended to reduce imaging errors within an organization. Based on the research and findings of Robert S. Pyatt, MD, and Chambersburg Imaging Associates (CIA), Chambersburg, Pa, where Pyatt is CEO, implementing a structured plan or template can pinpoint why imaging errors occur and bring forth methods to reduce these errors. CIA advocates the development of a group performance “dashboard” and measurement system specific to the requirements of the individual organization. Critical to the success of such an initiative is the creation of a culture where all radiologists “own” the quality of diagnostic imaging and actively pursue error-free results through practice-wide conformity to American College of Radiology (ACR) standards and guidelines, as well as other defined measures.
CIA is a group of 12 full-time and four part-time radiologists in South Central Pennsylvania. In the past year, they have performed more than 200,000 procedures in three hospitals and three outpatient centers, managing the imaging needs of 200,000 people and covering 2,000 square miles. Through unified management and a structured outline of practice-wide protocols, the group has developed a system of practice that emulates a pilot’s checklist in a preflight ritual. Just as a preflight checklist can save the lives of a pilot and his passengers, a protocol-unifying template can save the lives of patients and reduce errors. CIA devises many differentÂ protocols, each one specific to a different quality instrument. These checklists can be found in different forms in the necessary locations in the department. Each member of the group will face similar problems and also serve as a local expert for radiologists who have questions on a case. This teamwork theory for error reduction is evident not only in the medical profession but has been instrumental in many national and international corporations as well. Training and education in teamwork have shown significant improvements in quality through major industry efforts at such companies as General Electric, Motorola, Federal Express, and Ritz Carlton. The use of performance teams, and other methods, has earned some companies the prestigious Baldrige Award.
Whether an industry giant or a radiology group, every organization should begin its quality improvement (QI) initiative with a vision. To attain the vision, the group must first agree on what it means to be the most-improving radiology group in the nation. This requires full participation from every member, and each must be on the same page in questioning what the group is trying to achieve. CIA maintains, for instance, a monthly agenda that lists the areas for QI for each member, with regular improvements expected.
Defining the Agenda
Once the specifics of the group’s vision have been finalized, it is necessary to implement a quality plan covering the agreed-on quality measures. To continue the airplane analogy, instrument readings useful in the practice of radiology might indicate whether your tank of leadership is running full or if the gauge reads empty. Leadership includes participating in key medical staff and hospital committees, assuming leadership roles in the community, mentoring prospective high school students, teaching skeletal anatomy to elementary students, or funding scholarships in health care for local high schools. For example, the radiologist responsible for group-wide obstetric sonography would create a reporting template based on referring physicians’ needs (see Figure 1, page 64). Each radiologist must comply with all elements in his or her dictation. Similarly, all other quality assurance (QA) components are developed, implemented, and checked for compliance. Instruments should be built to measure levels of customer satisfaction, film quality, mammography-pathology correlations, pulmonary CT angiography accuracy, carotid Doppler accuracy, stroke diagnosis accuracy, stage of breast cancer at diagnosis, use of the ACR Breast Imaging Reporting and Data System (BI-RADSÂ®) lexicon, compliance with reporting protocols (OB/GYN sonography), sentinel lymph node (SLN) lymphoscintigraphy and outcomes, spiral renal CT for calculi, thallium correlation with cardiac catheterization, and arthroscopy with MRI.
Quality Improvement Initiative Checklist
To begin a quality improvement initiative:
List a common set of agreed-on quality measures and goals.
Choose group leaders to help the practice arrive at these goals.
Mentor one another.
Comb the literature for information.
Work to reduce variation and improve the practice’s baseline level.
Improve peer review.
Earn CME credit through this entire process.
As does a pilot, use checklists to ensure the patient’s safety.
Provide leadership to other medical staff members and the community.
Accept the fact that in the current environment, improving quality means denying revenue that often comes to other groups.
Network with other radiologists to learn from one another.
Work with state radiology societies and the American College of Radiology to share experiences and improve performance among peers.
In launching its QI program, CIA began with just a few objectives 15 years ago. More protocols were developed over the years, and today, the company keeps up-to-date with 15 total, five of which are active at one time. As a program gets rolling, it is important to update at least once a month, but if progress is made, measurementsÂ may be updated once a year, more or less, depending on the issues.
When developing these instruments for improved quality, it is important for all members in the group to understand that everyone owns quality. To facilitate these practices and promote ownership, everyone in the group must be delegated to specialize in one or more of the outlined ideas and empowered to ensure that the time frames, expectations, and protocols of each are understood and practiced by all participants. In most cases, you will need to diversify, allocating each member a specific duty of specialty and utilization management. Billing and other support staff can be enlisted to assist in collecting data and charting. Federal law has provided some guidance for developing quality improvement initiatives in mammography through the Mammography Quality Standards Act (MQSA), while the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has created opportunities for other QI initiatives. Through JCAHO, radiologists can utilize CME educational programs, a journal, a Web site, and highly trained consultants to reduce error.
The Role of Error
If an interest in excellence does not motivate a group to implement a quality-improvement program, the threat of malpractice could be the incentive. The issue is a constant threat, particularly in states like Pennsylvania, where the malpractice insurance crisis is most acute. Pennsylvania Medical Society Liability Insurance Company (PMSLIC) malpractice data reveal Pennsylvania as ranking among the top five most litigious states in the nation. Annual settlements in Philadelphia recently exceeded those for the entire state of California. In their lifetimes, one in five OB-GYNs, one in six surgeons, and one in six radiologists lose a malpractice suit.
|Figure 1. Complaints from referring physicians regarding highly variable reports with little consistency or completeness led CIA to create a customer-driven report compliant to all obstetric sonography (OB/sono) physicians’ needs in the region. This customized worksheet is the result of informative meetings with all physicians who utilize OB/sono reports. A variety of in-services was necessary to educate physicians and technologists about all information found on the worksheet. After creating this protocol, CIA has received zero complaints about insufficient information in the past year.|
Of the suits, 70% result in no payment to the patient and cost $20,000 on average to defend. If the case makes it to court, the average cost escalates to $95,000, and the average indemnity and defense total $213,000.1 Missed diagnosis accounts for 38% of paid claims, and imaging is considered in this grouping. The category of missed diagnosis can be broken into overriding and misinterpretation (false positives and false negatives); faulty reasoning with overriding and misinterpreting (true positives with misclassification); and lack of knowledge (such as medical history, symptoms, and unique imaging findings). According to Lucien Leape, MD, an expert in quality improvement in medicine, “Errors may be defined as an unintended act (by omission or commission) or one that does not achieve its intended outcome.”3 In medicine, unintended acts and outcomes can be costly in many ways.
Despite advances in training and technique, little change in the radiology error rate has occurred over the past 50 years. The average significant error rate has been reported in the literature to range around 2% to 20%.3 The internal error rate by the same radiologist can range as high as 25% to 30%.4 Eighty percent of errors are perceptual errors, which are present on the film but not seen. Factors such as a busy or noisy reading room, or a fatigued radiologist on call at 3 AM, can cause these perceptual errors. Some radiologists report that their error rates have increased with the marked increase of night-call duties and lengthened working hours.5 These error rates can be diminished with the use of dedicated nighthawk radiologists, who may be overseas or based in the United States.
Major issues with errors can surface in radiology if a “preflight checklist” is not used in dictating a radiology procedure. Often a simple mistake could have been avoided if some basic protocol had been followed. In the box on this page, some major issues of legal vulnerability are identified, all representing lost litigation cases that could have been avoided had a structured dictation outline been followed by the radiologist.
By using reporting protocols and, more important, by setting dictation protocols, one can avoid most of these issues. With all members of the group on the same page, it should be routine to obtain prior films and reports as well as have more necessary clinical information. With the aid of local expert readers, fewer questions should arise in interpretation. Using the structure from the ACR Communications Standards allows a radiologist to standardize reports just as a pilot checks his preflight checklist before taking off. Group practices can measure compliance with the key elements of this standard to see how well they are doing and find opportunities for improvement.
Know that these protocols need to be customer driven and defined by each group because even specialties have specific needs. It is the duty of the local experts to establish technique protocols for intravenous pyelograms, MRI, CT, neck trauma, contrast administration, pulmonary embolism algorithms, mammography and accreditation standards, QC measures, and other radiology areas. Through this added organization and structure, there is less variation, and this is the basis for quality improvement. As in industry, how much variation in construction would you tolerate as a consumer? If a radiologist is five times more likely (a category 0 rate of 30% versus 6% for the rest of the group) to recommend further mammographic views than other members of his or her practice, is this completely acceptable? A radiologist who reads 3,000 mammograms a year with a category 0 rate of 30% will cause 720 women a year to have additional studies. While this earns significant revenues for the practice, it is the result of less than optimal quality. Sometimes, improving quality means sacrificing group practice revenue to a significant degree. If the CIA practice performed at the 30% level for category 0, they would earn an additional $300,000 per year compared to its group-wide category 0 rate of 6%. Unfortunately, the insurers would pay if the entire practice had a category 0 rate of 30%. Most insurers have no interest in or skills to help improve the quality of radiology.
Further techniques for reducing error in imaging can be realized in computer-assisted detection (CAD) technology or double reading for mammography, more future CAD, and Internet access in the reading room environment. A designed work cycle with logically placed night duty is essential to keep fatigue at bay and the office error free. Fatigue is one of the most commonly reported causes of errors, throughout all industries. Long-distance, dedicated radiologists working through the night in Australia and other nations, or in the United States, are thus an instrumental element in improving quality.
Issues Representing Lost Litigation
- Failure to consult prior study or report (a common cause of missed breast and lung cancers)
- Limitations in imaging technique (when a diagnostic procedure has limitations, it should be noted in the report, as per the ACR Communications Standards)
- Acquisition of inaccurate or incomplete medical history
- Lesion located outside area of interest (eg, lung base mass on a kidney-ureter-bladder film)
- Lack of knowledge (you might not see what you do not know)
- Failure to continue search after one finding (finding a large pneumothorax and missing a new lung nodule in the opposite lung)
- Failure to recognize a normal biological variant
- Failure to recommend other studies (This issue was pointed out at the ACR annual meeting in Washington, DC,6 recently. It includes other nonimaging studies where appropriate, such as colonoscopy for polyps seen at barium enema. Furthermore, the ACR Standards support this concept.)
The CIA Experience
Through quality improvement, significant reductions in error have been noted at CIA. With the help of CIA neuroradiologist subspecialist Henry Ching, MD, errors in diagnosing stroke on CT have fallen from the national average of 15% to less than 1%. This makes CIA one of the most accurate groups in the nation in diagnosing stroke. Based on a recent JAMA article, 49% of radiologists reading CT scans as part of a large study missed at least one stroke.7 CIA achieves its excellent numbers through extensive peer performance review and personal mentoring by Ching. Other group experts help with body imaging, ultrasonography, mammography, and nuclear medicine, for instance.
Further successful efforts include working as a team with the emergency department physicians and trauma surgeons and becoming more united through similar protocols. Efforts to improve imaging of acute cervical spine injury have led to a consistent and improved protocol, with no radiologist variation. In this instance, three views of the neck are taken with the collar on, as opposed to only one view in the past. Only with three views can an educated decision be made to remove the collar. This has also satisfied the trauma surgeons and statewide trauma protocols.
Lack of comparison with prior studies is a proven contributor to misdiagnosis, but CIA efforts to reduce error in chest radiographs by comparing images with priors when available have met with success. Radiologists consulted prior studies 88.2% of the time in comparison with the previously reported 65%. As a result, there is much less risk of missing lung cancer. Further efforts toward compliance in the abdomen/pelvic CT reporting protocol resulted in a jump from a baseline of 66.7% to a better value of 90%. This has resulted in a sharp drop-off in complaints from referring physicians, especially oncologists. Similarly, OB sonography-reporting template (Figure 1, page 64) compliance has soared to 99%, with a near complete elimination of complaints from OB-GYN physicians.
Effective peer review and consistently reporting imaging findings with less variation and a closer conformance to requirements are a necessity in quality improvement and have long been established in the world of business. The adage, “You can’t manage what you can’t measure,” should be well understood. One major imaging technology vendor uses the Trotter Matrix system to identify “errors” in customer service. This system ranks the best and the worst service representatives, and the best teach the worst. The best scores are outlined by a halo, and the worst worldwide scores are outlined by a coffin. This improvement method uses the phrase, “Coffins call Halos.” That is, the worst performers call the best and find out how they did it. In using the Six Sigma concepts, this company can perform at very high-quality levels. Many companies spend 10% to 15% of actual working time on “methods to improve quality,” resulting in the following quite remarkable benefits:Â lower cost, happier customers, less repair work, repeat customers, and market dominance.
The Health Policy Implications
At current quality levels, much can be improved in radiology nationwide. If the category 0 rate can be improved for CIA, then it can be improved nationwide, probably saving millions of dollars and many thousands of stressed women from having to have more unnecessary mammograms. Yet improved quality is not reimbursed by insurers. Most radiology practices do not have a focused, strong effort to improve quality. This quality improvement weakness is due primarily to a lack of basic education, medical culture, and ongoing CME in QI. Fortunately, there are some fine resources available, such as the recently updated ACR Practice Guidelines and Technical Standards, ACR CPI (continuous professional improvement) modules, and other resources.
Why is this happening? A survey conducted by the Pennsylvania Radiological Society revealed that most radiologists spend less than an hour per month improving quality, and most radiologists have never had any training in the discipline of quality improvement.8 There is no medical school training in quality improvement, nor is there any in residency or fellowship. QI is nonexistent on the Radiology Board examinations. It is not required for state licensure anywhere. A very small number of states require a few hours in Category 1 CME in the topics of error reduction or risk management. The Pennsylvania statewide radiology quality survey results indicate that radiologists believe that they should play a major role in decisions about imaging quality, particularly in the areas of communications with referring physicians, appropriateness of procedures, imaging outcomes, missed diagnosis and malpractice, and radiologist skill with multiple modalities.
Changes are slowly occurring with state licensing boards and board reexaminations. They are increasing accountability for quality and error reduction with all physicians, including radiologists, through nationwide reporting services.9 Improving quality will reduce litigation, ultimately improve the health care of patients, and save the nation many millions of wasted dollars. In many ways, radiology can be a role model for all medical specialty areas.
Christopher M. Shively is a contributing writer for Decisions in Axis Imaging News. He can be reached at [email protected].
- Data supplied to Robert S. Pyatt, MD, from PMSLIC, 2000.
- Leape L. Error in medicine. JAMA. 1994;272:1851â€”1857.
- Berlin L. Reporting the missed radiologic diagnosis: medicolegal and ethical considerations. Radiology. 1994;192:183â€”7.
- Goddard P, Leslie A, Jones A, Wakeley C, Kabala J. Error in radiology. Br J Radiol. 2001;74(886):949â€”51.
- Pyatt RS. Personal reference. Quality Change. Pennsylvania Radiological Society; 2003.
- American College of Radiology Annual Meeting; May 2003; Washington, DC.
- Schriger DL, Kalafut M, Starkman S, Krueger M, Saver JL. Cranial computed tomography interpretation in acute stroke: physician accuracy in determining eligibility for thrombolytic therapy. JAMA. 1998;279:1293-1297.
- Pennsylvania Radiological Society Statewide Survey, 2000.
- Federation of Medical Boards. Available at: www.docinfo.org/alp_faq.htm. Accessed October 21, 2003.